Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy

Endoscopic Ultrasound Embolization of Porto-Systemic Shunt for Management of Medically Refractory Hepatic Encephalopathy: A Randomized Trial

The goal of this clinical trial is to learn if endoscopic ultrasound guided (EUS guided) spontaneous porto-systemic shunt (SPSS) embolization works to treat refractory hepatic encephalopathy in adults. It will also learn about the safety of EUS guided embolization. The main questions it aims to answer are:

1. Does EUS guided embolization maintain an acceptable safety profile?
2. Does EUS guided embolization of large SPSS result in significant clinical improvement in patients with refractory hepatic encephalopathy?

Participants will:

1. Receive EUS guided embolization or medical management.
2. Receive follow-up EUS procedures one month after embolization for assessment of the shunt patency and development of varices (embolization group).
3. Receive follow-up every week for 4 weeks to assess degree of worst episode of hepatic encephalopathy via West Haven criteria.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis; Hepatic Encephalopathy; Portal Shunt Systemic
• Intervention / Treatment: Procedure: Interventional Radiology for shunt embolization/retrograde tranvenous obliteration; Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers University Hospital
      • Contact: Kaveh Hajifathalian, MD; Phone Number: 973-972-9814; Email: kh852@njms.rutgers.edu
      • Principal Investigator: Kaveh Hajifathalian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged ≥18 years with known cirrhosis
2. MRHE; defined as ≥2 episodes of hepatic encephalopathy, HE (as documented in an outpatient office visit or during an inpatient admission) within 6 months prior to enrollment despite medical therapy with lactulose and rifaximin
3. Admission to inpatient hepatology floor at University Hospital-Newark with MRHE at the time of enrollment
4. Presence of a spontaneous portosystemic shunt; confirmed on CT/MRI at the index admission.

Exclusion Criteria:

1. Severe/refractory ascites defined as ascites that does not recede after medical therapy or reoccurs shortly after fluid has been removed
2. Refractory or recurrent bleeding from esophageal varices
3. Presence of portal vein thrombosis with complete occlusion
4. Hepatocellular carcinoma beyond Milan criteria or other advanced malignancy with limited life expectancy (<6 months)
5. Platelet count of less than 35,000 and/or INR of more than 2 which cannot be corrected for the EUS guided embolization procedure.
6. Hepatic venous occlusion, or right heart failure as the etiology of cirrhosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional Radiology guided embolization/retrograde tranvenous obliteration of shunt; Embolization of the porto-systemic shunt will be conducted via Trans-Jugular, Trans-Femoral, or direct Trans-hepatic access to embolize the shunt using cyanoacrylate glue, Sodium TetraDecyl Sulfate, Gelfoam, and/or vascular coil injection. The procedure will be performed under deep sedation or general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.	Procedure: Interventional Radiology for shunt embolization/retrograde tranvenous obliteration; Interventional Radiology (IR) embolization of a splenorenal shunt (specifically Spontaneous Splenorenal Shunts - SPSS) is a minimally invasive procedure, often using Balloon-Occluded Retrograde Transvenous Obliteration (BRTO) or coils, to treat severe, refractory hepatic encephalopathy caused by blood bypassing the liver. It forces blood back through the liver, improving function, but carries risks of increased portal pressure, ascites, or worsened varices.
Experimental: Endoscopic ultrasound guided embolization of shunt; Embolization of the porto-systemic shunt will be performed via endoscopic ultrasound (EUS) transesophageal or transgastric access with a 19G fine-needle aspiration (FNA) EUS needle to embolize the shunt using cyanoacrylate glue and vascular coil injection. The procedure will be performed under general anesthesia, with fluoroscopic guidance and intraprocedural antibiotic prophylaxis.	Procedure: Endoscopic ultrasound-guided transgastric embolization of the spontaneous portosystemic shunts; Coils are deployed at identifiable angulated points and in sequential manner until there a cessation of flow in SPSS on doppler monitoring; glue is then injected counter to blood flow and upstream (i.e. towards spleen) from the coils to maximize intraluminal polymerization and reduce risk of embolization. Size and number of coils will vary on a case by case basis according to the size of the SPSS, and coils with a size of at least 25% larger than the size of the SPSS will be used as standard sizing. Coils will be inserted using a 19 gauge fine needle via an endoscopic ultrasound through an either transgastric/transduodenal approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of hepatic encephalopathy	Grade of worst episode of hepatic encephalopathy (HE) during a 4-week period after intervention as measured by West Haven criteria at one week intervals after intervention, (see below for a copy of West Haven Criteria) administered via telephone encounters by study personnel. West Haven Criteria: Grade 0 (Minimal/Covert): No detectable changes in personality or behavior; minimal deficits in fine motor skills or psychometric tests.; Grade 1 (Covert): Mild lack of awareness, shortened attention span, mild personality changes, and/or sleep-wake cycle disturbances.; Grade 2 (Overt): Lethargy or apathy, moderate disorientation to time, obvious personality changes, inappropriate behavior, and sometimes asterixis (flapping tremor).; Grade 3 (Overt): Severe confusion, stupor, somnolence, and disorientation to place/situation, but the patient remains rousable.; Grade 4 (Overt): Coma, with or without response to painful stimuli.	4 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of portal hypertensive gastrointestinal bleeding episodes	Number of episode of gastrointestinal bleeding due to portal hypertension, complications including esophageal varices, gastric varices, portal hypertensive gastropathy and gastric antral vascular ectasia.	90 days after intervention
Number of hospitalization for hepatic encephalopathy after intervention	Number of hospitalizations with hepatic encephalopathy over a 3-month period after intervention	90 days after intervention
Migration or systemic embolization of embolization materials	Yes = 1; No = 0	30 days after intervention
Intra-operative bleed	Yes = 1; No = 0	30 days after intervention
Development of new or worsening ascites	Yes = 1; No = 0	30 days after intervention
Development of new esophageal or gastric varices	Yes = 1; No = 0	30 days after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in liver function	change in participants MELD 3.0 and Child-Pugh scores at 30 days after intervention versus time of enrollment	30 days after intervention

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• Yang M, Qiu Y, Wang W. Concurrent spontaneous portosystemic shunt embolization for the prevention of overt hepatic encephalopathy after TIPS: A systematic review and meta-analysis. Dig Liver Dis. 2024 Jun;56(6):978-985. doi: 10.1016/j.dld.2023.10.013. Epub 2023 Nov 3.
• Ke Q, He J, Cai L, Lei X, Huang X, Li L, Liu J, Guo W. Safety and efficacy of interventional embolization in cirrhotic patients with refractory hepatic encephalopathy associated with spontaneous portosystemic shunts. Sci Rep. 2024 Jun 27;14(1):14848. doi: 10.1038/s41598-024-65690-1.
• Philips CA, Rajesh S, Augustine P, Padsalgi G, Ahamed R. Portosystemic shunts and refractory hepatic encephalopathy: patient selection and current options. Hepat Med. 2019 Jan 25;11:23-34. doi: 10.2147/HMER.S169024. eCollection 2019.
• Lynn AM, Singh S, Congly SE, Khemani D, Johnson DH, Wiesner RH, Kamath PS, Andrews JC, Leise MD. Embolization of portosystemic shunts for treatment of medically refractory hepatic encephalopathy. Liver Transpl. 2016 Jun;22(6):723-31. doi: 10.1002/lt.24440.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Metabolic Diseases; Digestive System Diseases; Liver Diseases; Brain Diseases, Metabolic; Liver Failure; Hepatic Insufficiency; Fibrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Liver Cirrhosis; Hepatic Encephalopathy
• Other Study ID Numbers: Pro2025000948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be recorded by study ID # (Pro2025000948) according to Rutgers University policy. Data will be securely stored via Microsoft One Drive Account under password protected RU secure network, only accessible by principle investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No